Posts

Posted on

Duluth Holdings Inc. to Report First Quarter 2021 Financial Results on June 3

MOUNT HOREB, Wis., May 04, 2021 (GLOBE NEWSWIRE) — Duluth Holdings Inc. (dba, Duluth Trading Company) (“Duluth Trading”) (NASDAQ: DLTH), a lifestyle brand of men’s and women’s casual wear, workwear and accessories, today announced that it will report first quarter 2021 financial results before market on Thursday, June 3, 2021.

A conference call and audio webcast with analysts and investors will be held on Thursday, June 3, 2021 at 9:30 am Eastern Time, to discuss the results and answer questions.

  • Live conference call: 844-875-6915 (domestic) or 412-317-6711 (international)
  • Conference call replay available through June 17, 2021: 877-344-7529 (domestic) or 412-317-0088 (international)
  • Replay access code: 10156187
  • Live and archived webcast: ir.duluthtrading.com        

To expedite entry into the call and avoid waiting for a live operator, investors may pre-register at http://dpregister.com/10156187 and enter their contact information. Investors will then be issued a personalized phone number and pin to dial into the live conference call. The first quarter 2021 earnings release can be accessed at ir.duluthtrading.com before market on Thursday, June 3, 2021.

About Duluth Trading

Duluth Trading is a growing lifestyle brand for the Modern, Self-Reliant American. Based in Mount Horeb, Wisconsin, we offer high quality, solution-based casual wear, workwear and accessories for men and women who lead a hands-on lifestyle and who value a job well-done. We provide our customers an engaging and entertaining experience. Our marketing incorporates humor and storytelling that conveys the uniqueness of our products in a distinctive, fun way, and our products are sold exclusively through our content-rich website, catalogs, and “store like no other” retail locations. We are committed to outstanding customer service backed by our “No Bull Guarantee” – if it’s not right, we’ll fix it. Visit our website at www. duluthtrading.com.

Investor and Media Contacts:

Donni Case (310) 622-8224
Margaret Boyce (310) 622-8247
Financial Profiles, Inc.
[email protected]



Posted on

Splunk to Announce Fiscal 2022 First Quarter Results on June 2, 2021

Splunk to Announce Fiscal 2022 First Quarter Results on June 2, 2021

SAN FRANCISCO–(BUSINESS WIRE)–Splunk Inc. (NASDAQ: SPLK), provider of the Data-To-Everything Platform, will report results for its first quarter ended April 30, 2021 on Wednesday, June 2, 2021. Results will be included in a press release with accompanying financial information that will be released after market close and posted on the Splunk Investor Relations website.

Splunk’s executive management team will host a conference call beginning at 1:30 p.m. PT (4:30 p.m. ET) to discuss financial results and business highlights. Interested parties may access the call by dialing (866) 501-1535 in the U.S. or (216) 672-5582 from international locations. In addition, a live audio webcast of the conference call will be available on the Splunk Investor Relations website at http://investors.splunk.com.

Shortly after the conclusion of the conference call, a replay of the audio webcast will be available on the Splunk Investor Relations website for approximately seven days.

About Splunk Inc.

Splunk Inc. (NASDAQ: SPLK) turns data into doing with the Data-to-Everything Platform. Splunk technology is designed to investigate, monitor, and analyze and act on data at any scale.

Splunk, Splunk>, Data-to-Everything, D2E and Turn Data Into Doing are trademarks and registered trademarks of Splunk Inc. in the United States and other countries. All other brand names, product names, or trademarks belong to their respective owners. © 2021 Splunk Inc. All rights reserved.

Media Contact

Richard Brewer-Hay

Splunk Inc.

[email protected]

Investor Contact

Ken Tinsley

Splunk Inc.

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Networks Internet Data Management Technology Software

MEDIA:

Posted on

Abpro Announces Presentation and Data at the 2021 Annual Association for Research in Vision and Ophthalmology of ABP201 for the Treatment of Wet Age-related Macular Degeneration

  • Data showed reduction of neovascular lesion formation and vascular leakage in a rodent model of choroidal neovascularization

  • ABP201 performed equally or better than aflibercept in lesion inhibition and vascular leakage

WOBURN, Mass., May 04, 2021 (GLOBE NEWSWIRE) — Abpro Corporation, a clinical stage biotechnology company developing next-generation antibody therapies, today announced results from its study of ABP201, a novel bispecific antibody co-targeting VEGF and ANG2, for treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Results were also shared in a poster presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting on Monday May 3rd, 2021.

“The results from our preclinical study are very encouraging for the potential of ABP201 to treat patients affected by Wet AMD and DME,” said Ian Chan, chief executive officer of Abpro. “Bispecific antibody-based treatments for vascular diseases of the eye are promising. This data, which demonstrate equal or better performance to the standard of care in these animal models of neovascularization, is a significant step forward in the company’s ophthalmology program and warrants further evaluation of ABP201 in clinical, in-human studies.”

The study assessed the activity of ABP201 for the treatment of angiogenetic eye pathologies, using a rat laser-induced choroidal neovascularization (CNV) disease model. Abpro is developing ABP201 to treat vascular diseases of the eye, namely diabetic macular edema and wet age-related macular degeneration, that are a result of abnormal neovascularization. ABP201 is a novel tetravalent, bispecific antibody co-targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (ANG-2), both of which play a role in angiogenic pathways.

Study Conclusions:

  • ABP201 reduced neovascular lesion formation and vascular leakage in the rodent model of CNV.
  • ABP201 performed equally or better than aflibercept/Eylea for inhibition of lesion formation and vascular leakage.
  • This treatment could improve the efficacy and durability compared to the current VEGF therapies on the market.

About Abpro 
  
Abpro Corporation is a clinical stage biotechnology company located in Woburn, Massachusetts. The Company’s mission is to improve the lives of mankind facing severe and life-threatening diseases with next-generation antibody therapies. Abpro’s DiversImmuneTM platform has been used successfully to generate monoclonal antibody therapies against 300 traditionally difficult targets. The DiversimmuneTM platform combines nano-immunology, next-generation sequencing, advanced engineering and bioinformatics to create monoclonal antibody therapies against traditionally difficult targets. The Company has a pipeline of therapies to treat cancer, eye, autoimmune, infectious diseases and other areas. For more information, please visit www.abpro.com.  

Media Contact 
Michael Tattory 
LifeSci Communications 
1 (646) 751-4362 
[email protected]



Posted on

MineralTree to Showcase AP Automation Capabilities for Medical Practice Organizations at MGMA 2021 Conference

MGMA Medical Practice Excellence: Pathways Conference Digital Experience

CAMBRIDGE, Mass., May 04, 2021 (GLOBE NEWSWIRE) — MineralTree, an Accounts Payable (AP) and payments automation solution provider will be a featured sponsor at the Medical Group Management Association’s (MGMA) 2021 Medical Practice Excellence: Pathways Conference Digital Experience (MPE: Pathways Conference DX), taking place virtually from May 11-13, 2021.

MineralTree, a Corporate Member of MGMA, will be showcasing its accounts payable and payment automation platform and how it helps medical practice organizations streamline invoice capture and approvals, minimize paper-based payment processes, simplify financial audits, and take advantage of virtual cards and the valuable discounts and rebates that come with them.

The theme of this year’s MGMA conference is Follow Your Path: Finance | Operations | Data. The conference brings healthcare professionals together to choose the path that fits their day-to-day roles and responsibilities, and offers attendees access to the latest healthcare operations, data and financial education. The MPE: Pathways Conference DX will showcase five content tracks, 30 sessions, 50 speakers and opportunities to network with 2,000+ peers in a state-of-the-art digital experience.

Healthcare professionals can register here. Information on speakers, session details and schedule for the DX. Join the conversation on social media by following MGMA on Facebook, Twitter and LinkedIn.

About MGMA

Founded in 1926, the Medical Group Management Association (MGMA) is the nation’s largest association focused on the business of medical practice management. MGMA consists of 15,000 group medical practices ranging from small private medical practices to large national health systems representing more than 350,000 physicians. MGMA helps nearly 60,000 medical practice leaders and the healthcare community solve the business challenges of running practices so that they can focus on providing outstanding patient care. Specifically, MGMA helps its members innovate and improve profitability and financial sustainability, and it provides the gold standard on industry benchmarks such as physician compensation. The association also advocates extensively on its members’ behalf on national regulatory and policy issues. To learn more, go to MGMA.com or follow us on LinkedIn, Twitter and Facebook.

About MineralTree

MineralTree provides modern, secure, easy-to-use, end-to-end Accounts Payable (AP) Automation solutions that reduce costs by more than 75%, increase visibility and control, and mitigate fraud and risk, while improving cash flow. More than 3,000 mid-market and mid-enterprise companies, as well as more than 30 financial institutions rely on MineralTree to digitize and optimize the entire AP Automation and Payments process, preserving control over the complete invoice-to-payment workflow, improving vendor relationships, maximizing ROI, and transforming the finance function from a cost center to a profit center. For more information, visit https://www.mineraltree.com.



Media Inquiries
Tim Walsh
617.512.1641
[email protected]

Posted on

Soleno Therapeutics Announces Presentation of Positive Behavioral Data from Ongoing Extension Study of DCCR for Treatment of Prader-Willi Syndrome

Results Show Improvement in Multiple Behavioral Domains Following Treatment with DCCR

Data Presented in a Poster at the Pediatric Academic Societies Annual Meeting

REDWOOD CITY, Calif., May 04, 2021 (GLOBE NEWSWIRE) — Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the presentation of positive behavioral outcomes data from the Company’s ongoing open-label extension study (C602) of DCCR (diazoxide choline) Extended-Release tablets for patients with Prader-Willi Syndrome (PWS), at the Pediatric Academic Societies (PAS) 2021 Virtual Annual Meeting. The poster is available here.

As part of the ongoing Phase 3 program of DCCR in PWS, interviews are being conducted with caregivers of C602 study participants to characterize individual patient experiences with DCCR. The interviews are performed at multiple timepoints during the Phase 3 program by Casimir Inc., a rare disease research organization. The poster highlights the analysis of a subset of 48 interviews of caregivers whose child had received at least 13 weeks of DCCR treatment in C602. Folia Health, which utilizes a data driven platform to improve the treatment of chronic conditions, utilized a combination of natural language processing (NLP) and qualitative analytic techniques to process and analyze the transcript data from the caregiver interviews.

Through the 48 interviews, 39 behavioral outcomes were identified in seven outcome domains, with an average of 22±5.9 behaviors reported. The three most frequently reported domains were Food-seeking Behaviors (100%), Mealtime Behaviors (98%), and Daily Life Behaviors (98%). Twenty three percent of participants reported a negative behavior change and 6% reported more than one negative change. Most participants (83%) reported positive change in one or more behavioral outcomes on DCCR, more than 70% reported positive changes in one quarter or more of behaviors, while 48% reported positive changes in more than half of behaviors.

“It is exciting to see the utilization of natural language processing for the first time to determine caregiver sentiment in patients with PWS. NLP and other artificial intelligence techniques are the future of qualitative data analysis and can be particularly useful in rare-disease research. To my knowledge, this is the first report of the use of such techniques to understand the complex world of PWS outcomes,” said Deepan Singh, M.D., Vice Chair of Ambulatory Psychiatry, Maimonides Medical Center in Brooklyn, NY. “Behavioral abnormalities in PWS are heterogenous and very difficult to treat. I am encouraged by DCCR’s potential to impact these intractable problematic behaviors in individuals with PWS.”

“These important data provide critical insights into the long-term behavioral responses to DCCR in PWS, and support a more complete view of this promising investigational drug’s therapeutic benefits,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “The growing body of clinical evidence continues to indicate that DCCR has the potential to address the significant need for a safe and effective treatment for individuals with PWS. We remain firmly committed to working with the U.S. Food and Drug Administration to define the path forward for DCCR.”

About PWS

The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births in the U.S. The hallmark symptom of this disorder is hyperphagia, a chronic feeling of insatiable hunger that severely diminishes the quality of life for PWS patients and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. Hyperphagia can lead to significant morbidities (e.g., obesity, diabetes, cardiovascular disease) and mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior). In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia as the most important or a very important symptom to be relieved by a new medicine. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder. Diazoxide choline has received Orphan Drug Designation for the treatment of PWS in the U.S. and EU, and Fast Track Designation in the U.S.

About DCCR (Diazoxide Choline) Extended-Release Tablets

DCCR is a novel, proprietary extended-release dosage form containing the crystalline salt of diazoxide and is administered once-daily. The parent molecule, diazoxide, has been used for decades in thousands of patients in a few rare diseases in neonates, infants, children and adults, but has not been approved for use in PWS. Soleno conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS. The DCCR development program is supported by data from five completed Phase 1 clinical studies in healthy volunteers and three completed Phase 2 clinical studies, one of which was in PWS patients. In the PWS Phase 3 study, DCCR showed promise in addressing hyperphagia, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass and other metabolic parameters.

About Soleno Therapeutics, Inc.

Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, DCCR extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is currently being evaluated in a Phase 3 clinical development program. For more information, please visit www.soleno.life.

About Casimir Inc.

Casimir is a Contract Research Organization (CRO) that develops novel outcomes for decentralized and hybrid trials in order to better understand disease progression and treatment benefit. Casimir works with sponsors in over 20 rare diseases in every facet of clinical services from preclinical development to Phase IV and siteless studies. 

About Folia Health

Folia is a patient-driven Health-IOS (Individual Operating System) that enables individuals to easily take an active role in their care, while contributing to precision diagnostics, patient-centered drug development, & better care for complex diseases. Folia’s rich longitudinal data and proprietary analytic methods provide a vital and missing piece in the emergence of a home-centered, data-driven healthcare ecosystem. Discover how to harness the power of patient and caregiver knowledge at www.foliahealth.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding timing of any regulatory process or ultimate approvals and determining a path forward for DCCR for the treatment of PWS. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions, as well as risks and uncertainties inherent in Soleno’s business, including those described in the company’s prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Corporate Contact:

Brian Ritchie
LifeSci Advisors, LLC
212-915-2578



Posted on

TheMaven, Inc. Adopts Limited-Duration Stockholder Rights Plan

TheMaven, Inc. Adopts Limited-Duration Stockholder Rights Plan

NEW YORK–(BUSINESS WIRE)–
TheMaven, Inc. (OTC: MVEN) (“Maven” or the “Company”), a best-in-class technology platform empowering premium publishers who impact, inform, educate and entertain, today announced that the Special Finance & Governance Committee (the “Special Committee”) of the Maven Board of Directors (the “Board”) has adopted a limited-duration stockholder rights plan (the “Rights Plan”) to protect the best interests of all of the Company’s stockholders. The Rights Plan is effective immediately and will expire on May 3, 2022.

The adoption of the Rights Plan is intended to assure that all stockholders of the Company receive fair and equal treatment in the event of a proposed takeover of the Company, to guard against two-tier or partial tender offers, open market accumulations and other tactics designed to gain control of the Company without paying all stockholders a fair and adequate price, including sufficient premium for such controlling interest, and to enhance the Board’s ability to negotiate with a prospective acquiror. The Rights Plan is similar to those adopted by other publicly traded companies and includes a number of recognized stockholder protections that emphasize its limited focus and duration.

“The Maven Board of Directors is committed to creating long-term value and ensuring that our stockholders are able to realize the full potential of their investment in the Company,” said Maven Chairman John A. Fichthorn. “In the last year, we have made significant progress related to our financial reporting, a process that is nearing its conclusion. Accordingly, we believe that the Rights Plan adopted today will provide the Board with the flexibility to protect the best interests of the Company and its stockholders, and would still enable Maven to consider any legitimate offer that is fair and otherwise in the best interest of all stockholders. We remain focused on generating value for stockholders by growing the business and building on our position as a best-in-class technology and media company.”

In adopting the Rights Plan, the Special Committee declared a dividend distribution of one preferred stock purchase right (a “Right”) on each outstanding share of its common stock and the common stock issuable upon conversion of each share of the Company’s preferred stock. Each Right will initially entitle stockholders to buy one one-thousandth of a share of newly created Series L Junior Participating Preferred Stock of the Company, at an exercise price of $4.00, in the event the Rights become exercisable, subject to adjustment and the terms of the Rights Plan agreement.

In general, the Rights will become exercisable only if a person or group becomes the beneficial owner of 15% or more of the outstanding common stock of the Company or announces a tender offer for 15% or more of the outstanding common stock of the Company, including through such person’s ownership of the Company’s convertible preferred stock, as further detailed in the Rights Plan. The Board of Directors will, in general, be entitled to redeem the Rights at $0.001 per Right at any time before the triggering ownership threshold is crossed. Any stockholders with beneficial ownership of 15% or more of the outstanding common stock of the Company as of the time of this announcement are generally grandfathered at their current ownership levels, but the Rights Plan does not permit such shareholders to increase their ownership without triggering the Rights Plan.

This announcement is a summary only and is qualified by reference to the full text of the Rights Plan. Additional details regarding the Rights Plan will be contained in a Form 8-K to be filed by the Company with the U.S. Securities & Exchange Commission on or about May 4, 2021.

About Maven

Maven (maven.io) is a technology platform empowering premium publishers who impact, inform, educate and entertain. Maven operates Sports Illustrated Media and TheStreet, and powers more than 150 online destinations. Maven is publicly traded under the ticker symbol “MVEN”.

Cautionary Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements relate to future events or future performance and include, without limitation, statements concerning the Company’s business strategy, future revenues, market growth, capital requirements, product introductions, and expansion plans and the adequacy of its funding. Other statements contained in this press release that are not historical facts are forward-looking statements. The Company has tried, wherever possible, to identify forward-looking statements by terminology such as “may,” “will,” “could,” “should,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and other comparable terminology.

The Company cautions you that any forward-looking statements presented in this press release are based on the beliefs of, assumptions made by, and information currently available to, us. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties, and factors that are beyond the Company’s control or ability to predict. Although the Company believes that its assumptions are reasonable, they are not guarantees of future performance, and some will inevitably prove to be incorrect. As a result, the Company’s actual future results can be expected to differ from its expectations, and those differences may be material. Accordingly, you should use caution in relying on forward-looking statements, which are based only on known results and trends at the time they are made, to anticipate future results or trends. Certain risks are discussed from time to time in the Company’s filings with the SEC, including but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequently filed quarterly reports on Form 10-Q.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, the Company is not obligated to publicly release any revisions to these forward-looking statements to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Rachael Fink

Communications Manager, Maven

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Entertainment Communications Other Entertainment Technology Other Technology Software Other Communications

MEDIA:

Posted on

Exelixis Expands its Biotherapeutics Portfolio with Acquisition of GamaMabs Pharma’s First-in-Class Humanized Antibody Program Against a Novel Oncology Target

Exelixis Expands its Biotherapeutics Portfolio with Acquisition of GamaMabs Pharma’s First-in-Class Humanized Antibody Program Against a Novel Oncology Target

– Early clinical data of naked monoclonal antibodies support safety of targeting anti-Müllerian hormone receptor 2 (AMHR2), an oncology target of interest –

– Antibody-drug conjugates (ADCs) targeting AMHR2 could provide clinical efficacy in gynecologic, colorectal and other forms of cancer –

ALAMEDA, Calif. & TOULOUSE, France–(BUSINESS WIRE)–
Exelixis, Inc. (Nasdaq: EXEL) and GamaMabs Pharma SA today announced that they have entered into an agreement under which Exelixis will, upon the future closing of the asset purchase and subject to certain conditions to closing, acquire all rights, title and interest in GamaMabs’ AMHR2 antibody technology. Exelixis will pay GamaMabs $5 million upon signing of the agreement, make additional payments upon completion of closing conditions, and make additional milestone payments after closing, contingent upon various events. Once the transfer is completed, Exelixis will control 100% of GamaMabs’ AMHR2 franchise technology including all assets pertaining to GamaMabs’ monoclonal antibody drug product murlentamab (GM-102).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210504005757/en/

“GamaMabs has generated a compelling body of preclinical data supporting the potential of AMHR2 as a target for novel oncology therapies and demonstrated the safety of an anti-AMHR2 monoclonal antibody in human clinical trials,” said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. “Based on these data, we believe that applying our ADC capabilities to GamaMabs’ panel of antibodies against AMHR2 could yield a promising new addition to our biotherapeutics portfolio. Acquiring GamaMabs’ extensive know-how related to this target, as well as existing drug product and related manufacturing cell lines, will allow us to reduce significantly the development timeline compared with starting an AMHR2 program de novo. This is consistent with our strategy of advancing novel cancer therapies as rapidly as possible in order to enable new treatment options that may provide improved patient benefit.”

While AMHR2 expression is normally restricted to ovary, testis and adrenal tissues, it is also expressed in ovarian, endometrial, renal, liver, colon and lung tumors. Murlentamab, a monoclonal antibody targeting AMHR2, was well tolerated when administered on its own in Phase 1 and 2 studies, with no dose-limiting toxicities observed. In early 2021, GamaMabs discontinued development of murlentamab given the modest single-agent efficacy observed in these trials. Although it does not have plans to move murlentamab forward, Exelixis is encouraged by the potential of the AMHR2 target as it pursues the further discovery and development of novel biologics.

“The preclinical and clinical data generated to date for murlentamab support its first-in-class potential in a variety of cancer indications, and we expect that Exelixis’ ADC capabilities and expertise in the development and commercialization of novel cancer therapies will help to realize the full potential of this antibody in addressing unmet patient need,” said Stéphane Degove, Chief Executive Officer at GamaMabs. “We believe that placing our AMHR2 franchise with Exelixis will enable rapid and effective development of AMHR2-targeting cancer therapies while providing us with near-term revenue that can support development of our other pipeline programs and technologies.”

About GamaMabs Pharma

GamaMabs Pharma, a French immuno-oncology biotechnology company, is a leader in the development of optimized antibodies targeting AMHR2 for the treatment of cancer. GamaMabs’ first-in-class proprietary therapeutic monoclonal antibodies have the potential for broad applications in cancer. The company develops low-fucose EMABling® antibodies (license granted by LFB) with increased tumor cell killing properties through a breakthrough activation of immune cells.

About Exelixis

Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery – all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. In November 2020, the company was named to Fortune’s 100 Fastest-Growing Companies list for the first time, ranking 17th overall and the third-highest biopharmaceutical company. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

Exelixis Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: the clinical and therapeutic potential of ADCs targeting AMHR2 in gynecologic, colorectal and other forms of cancer; Exelixis’ immediate and future financial and other obligations under the asset purchase agreement with GamaMabs, including additional milestone payments after closing, contingent upon various events; Exelixis’ belief that applying Exelixis’ ADC capabilities to GamaMabs’ panel of antibodies against AMHR2 could yield a promising new addition to its biotherapeutics portfolio; and Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the continuing COVID-19 pandemic and its impact on Exelixis’ research and development operations; the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; uncertainties inherent in the drug discovery and product development process; Exelixis’ and GamaMabs’s adherence to their respective obligations under the asset purchase agreement, including the possibility that all requisite closing conditions will not be satisfied; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis’ continuing compliance with applicable legal and regulatory requirements; Exelixis’ ability to protect its intellectual property rights; market competition; changes in economic and business conditions; and other factors affecting Exelixis and its product pipeline discussed under the caption “Risk Factors” in Exelixis’ Annual Report on Form 10-K submitted to the Securities and Exchange Commission (SEC) on February 10, 2021, and in Exelixis’ future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a registered Japanese trademark.

Exelixis Investors Contact:

Susan Hubbard
Executive Vice President,

Public Affairs & Investor Relations

(650) 837-8194

[email protected]

Exelixis Media Contact:
Hal Mackins

For Exelixis, Inc.

(415) 994-0040

[email protected]

GamaMabs Investors Contact:
Stéphane Degove

Chief Executive Officer

[email protected]

GamaMabs Media Contact:

Céline Gonzalez

Andrew Lloyd & Associates

[email protected]

KEYWORDS: Europe United States North America France California

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Oncology Health FDA Medical Devices Genetics Clinical Trials

MEDIA:

Logo
Logo
Logo
Logo
Posted on

Vaxart Announces First Subject Enrolled in Phase 1b Norovirus Boosting Regimen Study

Study will evaluate safety and immunogenicity of multiple distinct dosing regimens of norovirus oral vaccine candidate

Norovirus infects 15% of U.S. children under age five every year

Study results may inform the COVID-19 oral vaccine program

SOUTH SAN FRANCISCO, Calif., May 04, 2021 (GLOBE NEWSWIRE) — Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that it has enrolled the first subject in a Phase 1b boosting regimen trial of its norovirus vaccine candidate. This study is designed to evaluate the safety and immunogenicity of various dosing intervals for Vaxart’s candidate, which is the only clinical stage norovirus oral tablet vaccine actively being developed.

In a health economic study published in the American Journal of Preventative Medicine in January 2021, the negative economic impact to the U.S. of norovirus was estimated to be approximately $10.5 billion* annually. Annual vaccine costs with an efficacy of 75% were cost effective and cost saving at ≤$1,600 and ≤$1,300 per year, respectively, for preschool-aged children, and ≤$165 and ≤$100 per year, respectively, for older adults.

“Norovirus is a potentially fatal illness that affects around 20 million Americans annually. It has an enormous impact on young families with 15% of children under age five being infected every year in the United States,” said Andrei Floroiu, Vaxart’s chief executive officer. “The WHO designated norovirus as a priority disease for vaccine development, as it is a major public health problem with no approved vaccine available, having a multi-billion dollar annual impact in the US alone and significantly more globally.”

Sean Tucker, Ph.D., chief scientific officer of Vaxart commented, “This study will provide insight into the optimal booster timing to maximize immunogenicity and total response of our oral norovirus vaccine candidate. Additionally, the findings may provide important information into the overall dynamics of our platform technology that could guide future protocols for our other vaccine candidates, including our oral COVID-19 tablet vaccine candidate, which is estimated to enter Phase 2 clinical trials around mid-year.”

Norovirus is an enteric pathogen that infects epithelial cells of the small intestine. Vaxart’s VP1-based bivalent oral tablet vaccine candidate targets the norovirus GI.1 Norwalk and GII.4 Sydney strains, which are the predominant strains affecting humans.

The booster regimen trial is the second of four Vaxart norovirus trials that are ongoing or are planned for 2021. Vaxart is currently administering a second booster dose to a subset of subjects who had participated in the prior Phase 1b bivalent study. The Company is also scheduled to initiate an age escalation trial in subjects over 65 years old and plans to launch a Phase 2 challenge study later this year.

VXA-NVV-105 Phase Booster Regimen 1b Trial Design

The Phase 1b study is designed to enroll 30 subjects aged 18 to 55 years old. Subjects will be randomized into 3 cohorts: Cohort 1 will receive the vaccine candidate on day 1 and week 4 of the study; Cohort 2 will receive the vaccine candidate on day 1 and week 8 of the study; Cohort 3 will receive the vaccine candidate on day 1 and week 12 of the study. The endpoints are safety and immunogenicity. For more information, refer to ClinicalTrials.gov.

* Note: The $10.5 Billion annual economic impact of norovirus infections in the US includes both direct medical costs and indirect costs such as time off work, school, etc.

About Vaxart

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the Company to develop oral analogs of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “plan” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates and clinical results and trial data, potential insights from Vaxart’s Phase 1b norovirus study, the potential role of Vaxart’s platform technology expectations regarding the timing and nature of future developments and announcements, including those related to trials and studies; the potential applicability of results seen in our preclinical studies or trials to those that may be seen in humans or clinical trials; and Vaxart’s expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s or its partners’ control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to resolve pending legal matters; Vaxart’s ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

Contacts

  
Media Relations:
Gloria Gasaatura
LifeSci Communications
(646) 970- 4688
[email protected]		 Investor Relations:
David R. Holmes
LifeSci Advisors, LLC
(646) 970-4995
[email protected]



Posted on

Mayfair Gold Provides Drilling Update and Announces Completion of Heli-Borne Magnetic Survey at the Fenn-Gib Gold Project, Northern Ontario

  • Over 10,000 meters of infill and expansion drilling completed to date
  • First property-wide triaxial magnetic survey completed
  • Drill target selection underway for regional exploration program


NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION, DISTRIBUTION OR DISSEMINATION DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES

VANCOUVER, British Columbia, May 04, 2021 (GLOBE NEWSWIRE) — Mayfair Gold Corp. (“Mayfair” or the “Company”) (TSX-V: MFG) is pleased to provide an update on its fully funded 2021 ongoing gold exploration program on its 100% owned Fenn-Gib Project (“Fenn-Gib”), located 80 kilometers east of Timmins, in northern Ontario.

Infill and expansion drilling commenced within three weeks following the acquisition of Fenn-Gib and has progressed well, with over 10,000m of the planned 50,000m drill program completed to date. The drill program includes both infill and step-out drilling at 25m to 50m centers and is designed to expand the gold mineralized zones beyond the current resource.

Mayfair Gold President and CEO Patrick Evans commented: “We are very pleased with the excellent progress being made at Fenn-Gib. With three drill rigs active, we are currently well on track to achieve our planned 50,000m drill program.”

Mr. Evans added: “We are also pleased to have completed the first ever heli-borne high-resolution triaxial MAG survey at 75-metre spaced flight lines over both the North and South blocks at Fenn-Gib. Based on initial results, target selection has commenced and plans are underway to mobilize additional drill rigs to Fenn-Gib to support a regional exploration program.”

Although drilling at Fenn-Gib is progressing very well, the turnaround time at the assay laboratories remains slow. Mayfair has contracted a second assay laboratory to improve the turnaround time. Numerous assay results are pending and will be reported when received and compiled.

About Mayfair Gold

Mayfair is a Canadian mineral exploration company focused on advancing the 100% owned Fenn-Gib gold project in the Timmins region of Northern Ontario. The Fenn-Gib gold deposit is Mayfair’s flagship asset. An updated open-pit constrained NI 43-101 resource estimate (February 5, 2021) reported a total Indicated Resource of 70.2M tonnes containing 2.08M ounces at a grade of 0.921 g/t Au and an Inferred Resource of 3.8M tonnes containing 75,000 ounces at a grade of 0.618 g/t Au. The deposit has a strike length of approx. 1.25km with widths ranging up to 300m. The gold mineralized zones remain open at depth and along strike to the east and west.

For further information contact:

Patrick Evans, President and CEO
Email: [email protected]
Phone: (416) 670-5114
Web: www.mayfairgold.ca

Qualified Person Statement

Mayfair Gold’s disclosure of technical and scientific information in this news release has been reviewed and approved by Howard Bird, P Geo., Vice President Exploration for the Company, who serves as a Qualified Person under the definition of National Instrument 43-101.

Forward Looking Statements

This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, “forward-looking statements“) that relate to Mayfair’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result”, “are expected to”, “expects”, “will continue”, “is anticipated”, “anticipates”, “believes”, “estimated”, “intends”, “plans”, “forecast”, “projection”, “strategy”, “objective” and “outlook”) are not historical facts and may be forward-looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.

Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Mayfair’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID-19 pandemic and other factors. Mayfair undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Mayfair to predict all of them, or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.



Posted on

IPG Photonics Announces CEO Transition

 Eugene A. Scherbakov, COO, to become CEO

Valentin P. Gapontsev, CEO, to transition to Executive Chairman of the Board and remain active

OXFORD, Mass., May 04, 2021 (GLOBE NEWSWIRE) — IPG Photonics Corporation (NASDAQ: IPGP) today announced a management change, which is effective immediately.

Eugene A. Scherbakov Ph.D., currently Chief Operating Officer, Managing Director of IPG Laser GmbH, Senior Vice President, Europe and Director, succeeds Valentin P. Gapontsev, Ph.D., as IPG Photonics’ Chief Executive Officer. Dr. Valentin Gapontsev, founder of the Company and current CEO and Chairman of the Board, becomes Executive Chairman and continues his involvement in directing research and development and strategy.

“Dr. Scherbakov’s technological knowledge as well as extensive understanding of the Company’s operations, sales and customers contributed significantly to IPG’s success since he joined us in 1995,” said Dr. Valentin Gapontsev. “Dr. Scherbakov’s leadership at our German operations and expertise resulted in operational excellence and lower production costs for our vertical integration model, making fiber laser technology more cost competitive with traditional materials processing technologies, while preserving IPG’s strong profitability and industry-leading margins.” Dr. Gapontsev continued, “The technology and product opportunities for IPG are enormous and I look forward to spending more time on our technical strategy. It’s an exciting evolution for me and a very good transition for the Company.”

“I feel extremely privileged to become the next CEO of this great company,” said Dr. Scherbakov. “I look forward to continuing the strategy of Dr. Gapontsev and building on the strong foundation he set in place. We are lucky that he will continue as Executive Chairman.”

“It is hard to overstate Dr. Gapontsev’s contribution to fiber lasers and IPG, as an inventor, entrepreneur and visionary,” said John Peeler, Lead Independent Director. “This implements the succession plan discussed by the IPG Board for some time. Dr. Scherbakov is uniquely qualified for his new role.”

Dr. Scherbakov has served as Managing Director of IPG Laser GmbH, IPG’s German subsidiary, since August 2000, Senior Vice President-Europe since February 2013 and Chief Operating Officer since February 2017. He has been a member of its Board of Directors since 2000.

About IPG Photonics Corporation

IPG Photonics Corporation is the leader in high-power fiber lasers and amplifiers used primarily in materials processing and other diverse applications. The Company’s mission is to make its fiber laser technology the tool of choice in mass production. IPG accomplishes this mission by delivering superior performance, reliability and usability at a lower total cost of ownership compared with other types of lasers and non-laser tools, allowing end users to increase productivity and decrease costs. A member of the S&P 500® Index, IPG is headquartered in Oxford, Massachusetts and has more than 30 facilities worldwide. For more information, visit www.ipgphotonics.com.

Contact

Eugene Fedotoff
Director of Investor Relations
IPG Photonics Corporation
508-597-4713
[email protected]